An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT05900141
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Hyperlipoproteinemia (a)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pelacarsen — DRUGPelacarsen 80mg s.c. monthly
Study Details
This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).
Key Dates
- Start date
- Sep 29, 2023
- Status verified
- Jul 2025
- Primary completion
- Aug 24, 2028
- Completion
- Aug 24, 2028
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pelacarsen (TQJ230)open-label pelacarsen 80 mg
Primary Outcome Measure
Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs. [ Time Frame: 60 months ]